Skip to content

Guider Softip XF recallZ-0017-2024 · Boston Scientific Corporation · initiated Jul 27, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Stryker Neurovascular has observed that certain lots of Guider Softip XF Guide Catheters appear to have the incorrect tip curve shape. The impacted products were distributed with a tip curve shape which differs from the labeled tip curve shape.

FDA root cause category: Employee error

What the company is doing

Stryker issued an URGENT: MEDICAL DEVICE VOLUNTARY Recall notice to it consignees on 07/31/2023. The notice explained the issue, potential risk, and required the following actions be taken: 1. Immediately check your internal inventory for affected devices. 2. Segregate the affected units in a secure location for return to Stryker. 3. Circulate this Recall-Removal notice internally to all interested/affected parties. 4. Maintain awareness of this communication internally until all required actions have been completed within your facility. 5. Inform Stryker if any of the subject devices have been distributed to other organizations. If yes, provide contact details so that Stryker can inform the recipients appropriately.

Recall details

Recall number
Z-0017-2024
Status
Open, Classified
Initiated by the company
Jul 27, 2023
Posted by the FDA
Oct 3, 2023
Recalling firm
Boston Scientific Corporation
Quantity
1728 units
Product code
DQY
Distribution
US Nationwide distribution in the state of Indiana.

Product description

Guider Softip Guide Catheter 6F PRE-SHAPED 40 100CM, Catalog number M003101420, cardiac guide catheter

Code information (models, lots, serial numbers)

GTIN 08714729244295, Lot/Batch Numbers: 26138711, 26276489, 26276490, 26590803, 26746110, 26891804, 26891805, 27162093, 27162094, 27203536, 27431372, 26059693, 26138710, 26276491, 26590802, 26746111, 27203537, 27219436, 27431373, 27526941, 27801040, 28811942, 28811943

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 92785).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page